LinkedInMarty Hughes

Marty Hughes

Associate Director of Research and Development at West-Ward Pharmaceuticals (formerly Bedford Laboratories)

Location
Cleveland/Akron, Ohio Area
Industry
Pharmaceuticals
Current
  1. West-Ward Pharmaceuticals
Previous
  1. PharmaForce,
  2. Sonus Pharmaceuticals,
  3. State of Washington
Education
  1. University of Washington School of Medicine
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327connections
West-Ward Pharmaceuticals

West-Ward Pharmaceuticals

Associate Director of Research and Development

– Present

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Background

Summary

Pharmaceutical scientist with expertise in product development, extensive managerial experience, and effective leadership skills

Experience

Associate Director of Research and Development

West-Ward Pharmaceuticals
– Present (3 years 9 months)Cleveland/Akron, Ohio Area

Hired in the role of Manager (03/11-07/12); currently hold the position of Associate Director (07/12-present), leading a team of 12 scientists developing parenteral generic medicines.
Overall responsibilities:
▪ Strategic planning for business development
▪ Staffing (recruiting, hiring, training, mentoring, coaching)
▪ Scientific due diligence for product selection
▪ Project planning and direction
▪ Oversight of all scientific and technical aspects of product development and launch, including:
- analytical method development and validation
- formulation development incorporating principles of QbD
- scale-up for cGMP manufacturing
- exhibit batch manufacturing
- stability monitoring and establishment of specifications
- ANDA development for regulatory submission
- FDA deficiency responses

Manager, Research and Development

PharmaForce
(3 years 1 month)Columbus, Ohio Area

Held the positions of Senior Scientist (03/08-01/10); and Manager (01/10-03/11).
Duties included:
▪ Management of day-to-day department operations
▪ Hiring and training of scientific staff
▪ Analytical method development and validation
▪ Formulation development
▪ Scale-up to exhibit batch manufacture (in-house and CMO)
▪ Exhibit batch stability monitoring and establishment of specifications
▪ Technical writing of Modules 2 and 3 for ANDA's.

Associate Director, Analytical Discovery

Sonus Pharmaceuticals
(6 years 10 months)Greater Seattle Area

Held positions of successive responsibility including Research Scientist (06/01-07/03); Manager, Analytical Chemistry (07/03-10/04); Associate Director, Analytical Discovery (10/04-03/08).
Duties included:
▪ Development and validation of novel analytical and bioanalytical methods
▪ Analytical support for drug substance and drug product development
▪ Bioanalytical support for preclinical and clinical studies
▪ Establishment and management of instrument qualification program
▪ Group management with 4 direct reports

Forensic Toxicologist

State of Washington
(1 year 7 months)Greater Seattle Area

Responsibilities included:
▪ Analysis of biological samples in support of law enforcement and death investigations
▪ Statistical analysis of blood alcohol testing results
▪ Method evaluation and implementation
▪ Serving as an expert witness in courts throughout Washington

Skills

  • Formulation
  • GMP
  • Analytical Chemistry
  • FDA
  • Technology Transfer
  • Pharmaceutical Industry
  • Chromatography
  • R&D
  • Biotechnology
  • Validation
  • Drug Discovery
  • GLP
  • Chemistry
  • Lyophilization
  • Bioanalysis
  • HPLC
  • LC-MS
  • Mass Spectrometry
  • Organic Chemistry
  • Pharmaceutics
  • Product Development
  • Regulatory Submissions
  • Team Leadership
  • Clinical Development
  • Drug Development
  • See 10+  See less

Education

University of Washington School of Medicine

Postdoc, Clinical Chemistry

Postdoctoral Fellowship in Clinical Chemistry with a specialty in TDM/Tox (Toxicology and Therapeutic Drug Monitoring)

University of Notre Dame

Ph.D., Chemistry

Specialty: Organic Chemistry
Areas of Focus: Molecular Recognition, Physical Organic Chemistry, Analytical Chemistry

Eastern Washington University

B.S., Chemistry

Pre-professional track

Activities and Societies: ACS Student Group

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